BZMClass II

Calculator, Pulmonary Function Interpretor (Diagnostic)

21 CFR 868.1900 / Anesthesiology

BZM is the FDA product code for Calculator, Pulmonary Function Interpretor (Diagnostic), a class II device type, regulated under 21 CFR 868.1900. As of 2026-09-10, FDA records hold 26 510(k) clearances under this code, the most recent dated 2011-03-04, and no recalls.

Classification record

Product code: BZM
Device name: Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation: 21 CFR 868.1900
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 26
Ingested recalls: 0

Clearances, product code BZM

By decision year

26 clearances under product code BZM with a decision year between 1977 and 2011, 1987 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code BZM by decision year
Year	Clearances
1977	1
1979	1
1980	2
1982	1
1984	2
1985	2
1986	1
1987	4
1988	2
1990	1
1991	1
1993	1
1996	1
1998	2
2002	1
2007	1
2009	1
2011	1

Applicants with the most clearances

Product code BZM

Applicants holding the most 510(k) clearances under product code BZM
Applicant	Clearances
Medical Graphics Corp.	7
Karmelsonix	3
Cybermedic, Inc.	2
Cavitron Corp.	1
Cdx Corp.	1
Cdx Corp.	1
Cyber Diagnostics	1
Futuremed Div. of Future Impex Corp.	1
Gomi Medical Instruments	1
Karmel Medical Acoustic Technologies, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code